Therapeutic and Protective Potential of Mesenchymal Stem Cells, Pharmaceutical
Agents and Current Vaccines Against COVID-19

Rasouli, Mehdi; Vakilian, Fatemeh; Ranjbari, Javad

doi:10.2174/1574888x16666201221151853

Cited by 8 publications

(1 citation statement)

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“…In preclinical studies employing animal models of lower-extremity ischemia, autologous and allogeneic MSCs produced from various sources, including bone marrow, adipose tissue, and prenatal sources, have been bene cial (19). Following this, many clinical trials have been conducted to demonstrate the feasibility and effectiveness of MSCs produced from multiple sources for the therapy of CLI as a consequence of positive preclinical research results (20).…”

Section: Introductionmentioning

confidence: 99%

Report of a phase 1 clinical trial for safety assessment of human placental mesenchymal stem cells therapy in patients with Critical limb ischemia (CLI)

Shirbaghaee

Keshel

Rasouli

et al. 2023

Preprint

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Background Critical limb ischemia (CLI) is associated with increased risk of tissue loss, leading to significant morbidity and mortality. Therapeutic angiogenesis using cell-based treatments, notably mesenchymal stem cells (MSCs), is essential for enhancing blood flow to ischemic areas in subjects suffering from CLI. The objective of this study was to evaluate the feasibility of using placenta-derived mesenchymal stem cells (P-MSCs) in patients with CLI. Methods This phase I dose-escalation study investigated P-MSCs in nine CLI patients who were enrolled into each of the two dosage groups (20 × 106 and 60 × 106 cells), delivered intramuscularly twice, two months apart. The incidence of treatment-related adverse events was the primary endpoint. The decrease in inflammatory cytokines, improvement in the ankle-brachial pressure index (ABI), maximum walking distance, vascular collateralization, alleviation of rest pain, healing of ulceration, and avoidance of major amputation in the target leg were the efficacy outcomes. Results All dosages of P-MSCs, including the highest tested dose of 60 × 106 cells, were well tolerated. During the 6-month follow-up period, there was a statistically significant decrease in IL-1 and IFN-γ serum levels following P-MSC treatment. The blood lymphocyte profile of participants with CLI did not significantly differ, suggesting that the injection of allogeneic cells did not cause T-cell proliferation in vivo. We found clinically substantial improvement in rest pain, ulcer healing, and maximum walking distance after P-MSC implantation. In patients with CLI, we performed minor amputations rather than major amputations. Angiography was unable to demonstrate new small vessels formation significantly. Conclusion The observations from this phase I clinical study indicate that intramuscular administration of P-MSCs is considered safe and well tolerated and may dramatically improve physical performance and minimize inflammatory conditions in patients with CLI. Trial registration: IRCT, IRCT20210221050446N1. Registered May 09, 2021.

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Section: Introductionmentioning

confidence: 99%